|Publication number||US8048158 B2|
|Application number||US 11/781,369|
|Publication date||Nov 1, 2011|
|Filing date||Jul 23, 2007|
|Priority date||Nov 27, 1996|
|Also published as||CA2405460A1, CA2405460C, DE60231686D1, EP1297799A2, EP1297799A3, EP1297799B1, EP2080491A1, EP2080491B1, US6554862, US7329281, US8562680, US20020072797, US20030135274, US20080015710, US20120053691|
|Publication number||11781369, 781369, US 8048158 B2, US 8048158B2, US-B2-8048158, US8048158 B2, US8048158B2|
|Inventors||Jo Hays, David Overaker, Joseph Contiliano, Joseph H. Sklar|
|Original Assignee||Depuy Mitek, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (104), Non-Patent Citations (3), Referenced by (8), Classifications (15), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation of U.S. patent application Ser. No. 10/387,674, filed Mar. 13, 2003, now issued as U.S. Pat. No. 7,329,281, which is a continuation of U.S. patent application Ser. No. 09/966,766, filed Sep. 28, 2001, now issued as U.S. Pat. No. 6,554,862, which is a continuation-in-part of U.S. patent application Ser. No. 09/789,398, filed Feb. 20, 2001, now abandoned, which is a continuation of U.S. patent application Ser. No. 09/304,885, filed May 4, 1999, now abandoned, which is a continuation of Ser. No. 08/756,413, filed Nov. 27, 1996, now issued as U.S. Pat. No. 5,899,938.
This invention relates to medical apparatus and methods in general, and more particularly to apparatus and methods for reconstructing ligaments.
Ligaments are tough bands of tissue which serve to connect the articular extremities of bones, or to support or retain organs in place within the body. Ligaments are typically composed of coarse bundles of dense white fibrous tissue which are disposed in a parallel or closely interlaced manner, with the fibrous tissue being pliant and flexible, but not significantly extensible.
In many cases, ligaments are torn or ruptured as a result of accidents. As a result, various procedures have been developed to repair or replace such damaged ligaments.
For example, in the human knee, the anterior and posterior cruciate ligaments (i.e., the ACL and PCL) extend between the top end of the tibia and the bottom end of the femur. The ACL and PCL cooperate, together with other ligaments and soft tissue, to provide both static and dynamic stability to the knee. Often, the anterior cruciate ligament (i.e., the ACL) is ruptured or torn as a result of, for example, a sports-related injury. Consequently, various surgical procedures have been developed for reconstructing the ACL so as to restore normal function to the knee.
In many instances, the ACL may be reconstructed by replacing the ruptured ACL with a graft ligament. More particularly, with such procedures, bone tunnels are typically formed in the top end of the tibia and the bottom end of the femur, with one end of the graft ligament being positioned in the femoral tunnel and the other end of the graft ligament being positioned in the tibial tunnel. The two ends of the graft ligament are anchored in place in various ways known in the art so that the graft ligament extends between the femur and the tibia in substantially the same way, and with substantially the same function, as the original ACL. This graft ligament then cooperates with the surrounding anatomical structures so as to restore normal function to the knee.
In some circumstances the graft ligament may be a ligament or tendon which is harvested from elsewhere in the patient; in other circumstances the graft ligament may be a synthetic device. For the purposes of the present invention, all of the foregoing can be collectively referred to as a “graft ligament”, “graft material” or “graft member.”
As noted above, the graft ligament may be anchored in place in various ways. See, for example, U.S. Pat. No. 4,828,562, issued May 9, 1989 to Robert V. Kenna; U.S. Pat. No. 4,744,793, issued May 17, 1988 to Jack E. Parr et al.; U.S. Pat. No. 4,755,183, issued Jul. 5, 1988 to Robert V. Kenna; U.S. Pat. No. 4,927,421, issued May 22, 1990 to E. Marlowe Goble et al.; U.S. Pat. No. 4,950,270, issued Aug. 21, 1990 to Jerald A. Bowman et al.; U.S. Pat. No. 5,062,843, issued Nov. 5, 1991 to Thomas H. Mahony, III; U.S. Pat. No. 5,147,362, issued Sep. 15, 1992 to E. Marlowe Goble; U.S. Pat. No. 5,211,647, issued May 18, 1993 to Reinhold Schmieding; U.S. Pat. No. 5,151,104, issued Sep. 29, 1992 to Robert V. Kenna; U.S. Pat. No. 4,784,126, issued Nov. 15, 1988 to Donald H. Hourahane; U.S. Pat. No. 4,590,928, issued May 27, 1986 to Michael S. Hunt et al.; and French Patent Publication No. 2,590,792, filed Dec. 4, 1985 by Francis Henri Breard.
Despite the above-identified advances in the art, there remains a need for a graft ligament anchor which is simple, easy to install, and inexpensive to manufacture, while providing secure, trouble-free anchoring of the graft ligament, typically in the knee joint of a mammal.
Accordingly, one object of the present invention is to provide an improved graft ligament anchor which is relatively simple in construction and therefore inexpensive to manufacture, relatively easy to handle and install, and reliable and safe in operation.
Another object of the present invention is to provide an improved method for attaching a graft ligament to a bone.
These and other objects of the present invention are addressed by the provision and use of a novel graft ligament anchor comprising graft ligament engagement means for disposition in an opening in a bone, such that a wall of the graft ligament engagement means resides adjacent to at least one graft ligament disposed in the opening, and locking means for disposition in the opening in the bone and at least partially engageable with the graft ligament engagement means. The elements of the graft ligament anchor are adapted such that movement of the locking means in the opening in the bone causes at least a part of the locking means to engage the graft ligament engagement means so as to urge the graft ligament engagement means, and hence the portion of the graft ligament disposed adjacent thereto, toward a wall of the opening in the bone, whereby to secure the graft ligament to the wall of the opening.
In use, an opening is made in the bone, and the graft ligament and the graft ligament engagement means are inserted into the opening, with a portion of the graft ligament being disposed alongside a wall of the graft ligament engagement means. In accordance with the present invention, the locking means are also positioned in the opening in the bone, alongside the graft ligament engagement means, with the locking means being separated from the graft ligament by a portion of the graft ligament engagement means. The method further includes moving the locking means in the opening in the bone so as to cause at least a portion thereof to urge the graft ligament engagement means, and hence the portion of the graft ligament disposed adjacent thereto, toward a wall of the opening, whereby to secure the graft ligament to the wall of the opening.
In one aspect of the invention, a graft fixation device for fixing a graft member within a bone tunnel includes a radially expandable sheath having a side wall with at least one structurally weakened fracture region extending longitudinally along a length of the sheath in the side wall. The radially expandable sheath is sized to fit within a bone tunnel so that a graft member may be accommodated between a wall of a bone tunnel and an outer surface of the radially expandable sheath. A sheath expander is disposable in a central lumen of the radially expandable sheath to radially expand the sheath so as to fix the graft member within the bone tunnel. The structurally weakened fracture region is adapted to fracture upon radial expansion of the sheath to allow varying amounts of radial expansion.
In specific embodiments of this aspect of the invention, a number of longitudinal side wall segments can be provided, the segments being connected by longitudinal fracture regions. The side wall segments can also have concave outer surfaces so that each segment can capture a portion of graft material between its outer surface and the bone tunnel wall. In a further embodiment, the segments can be longitudinally divided into subsegments connected by longitudinal flexion regions.
In another aspect of the invention, a graft fixation device for fixing a graft member within a bone tunnel includes a radially expandable sheath having a side wall comprising a plurality of longitudinal side wall segments separated by convex longitudinal flex regions having convex outer surfaces, the radially expandable sheath being sized to fit within a bone tunnel and defining a central lumen. In this aspect, the side wall segments are flexible and have a concave outer surface adapted to enclose a graft member between the concave outer surface and a bone tunnel wall. A sheath expander is disposable in the central lumen of the radially expandable sheath to flex the convex longitudinal flex regions and the flexible concave wall segments to radially expand the sheath so as to fix a graft member within a bone tunnel.
In specific embodiments of this aspect, the side wall segments may include rigid longitudinal subsegments connected by longitudinal flex regions to provide flexing within the segments. In addition, convex longitudinal flex regions may be configured to flex, but then fracture to allow further radial expansion of the sheath.
Graft fixation devices of the invention allow a wider variety of materials to be used to form the radially expanding sheath and can also allow a single sized sheath to be used with a larger variety of bone tunnel and expander sizes.
These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments of the invention, which are to be considered together with the accompanying drawings wherein like numbers refer to like parts, and further wherein:
Referring first to
The embodiment illustrated in
In operation, opening 24 is first made in bone B and then graft ligaments 28 and graft ligament engagement means 20 are inserted into opening 24, with graft ligaments 28 being disposed alongside a first wall, i.e., the interior wall 30, of sleeve 22. Locking means 32 are inserted into opening 24 alongside the exterior surface 40 of sleeve 22. Locking means 32 are thus separated from graft ligaments 28 by graft ligament engagement means 20, i.e., sleeve 22. As noted above, movement of locking means 32 causes at least a portion thereof to engage sleeve 22 and to crimp the sleeve inwardly upon graft ligaments 28, and to push both sleeve 22 and graft ligaments 28 against sidewall 38 of opening 24.
If it is desired to thereafter release graft ligaments 28, rocker arm 34 may be moved back to the position shown in
If desired, substantially all of sleeve 22 can be formed so as to be deformable; alternatively, some of sleeve 22 can be formed so as to be rigid. By way of example, the portion of sleeve 22 contacted by locking means 32 can be formed so as to be substantially rigid.
Graft ligaments 28 may comprise natural or synthetic graft ligament material, and the anchor can be used to attach natural or synthetic graft ligaments and/or tendons to bone. Sleeve 22 preferably is provided with inwardly-extending protrusions 42, such as spikes 44, for securely retaining graft ligaments 28 therein.
Locking means 32 may be a rocker arm type, such as the rocker arm member 34 shown in
In operation, the embodiments shown in
If and when it is desired to adjust tension on graft ligaments 28, locking means 32 may be backed off, that is, if locking means 32 comprise the rocker arm type cam member 34, the arm need only be rotated 90° from the positions shown in
Referring next to
In the attachment of one or more graft ligaments 28 to a bone B, using the embodiment of
Referring next to
In lieu of, or in addition to, the aforementioned concavities 56 shown in
In operation, rotative movement of rocker arm 34 (or axial movement of expansion plug 46) causes plates 60, 62 to move outwardly from each other so as to urge graft ligaments 28 against wall 38 of opening 24. Walls 50 of plates 60, 62 may be provided with concavities 56, as shown in
Referring next to
Upon screwing in expansion plug 46, the expansion plug engages first leg 98 of graft ligament engagement means 20 (i.e., the V-shaped strip 94) to force first leg 98 to close upon second leg 100 with the graft ligament end portion 96 sandwiched therebetween and, upon further screwing in of threaded expansion plug 46, to force graft ligament engagement means 20 and graft ligament 28 against wall 38 of opening 24. To release graft ligament 28, an operator need only back out expansion plug 46.
When attaching a graft ligament to a bone with the graft ligament anchor shown in
Still referring to
In a modification (not shown) of the
Looking next at
Looking next at
As shown in
Referring next to
In attachment of one or more graft ligaments 28 to a bone B, using the embodiment of
In attachment of one or more graft ligaments 28 to a bone, using the embodiment of
A further embodiment of the present invention is illustrated in
Referring again to
As illustrated in the cross-sectional view of
In particular, sheath 400 can include one or more structurally weakened fracture regions 490 extending longitudinally along a length of side wall 401. As used herein, structurally weakened refers to a feature that can allow flexion and/or fracture side wall 401, in some instances allowing the wall to flex as if it were hinged (and it is further contemplated that a hinge of any type could be a structurally weakened region). In a preferred embodiment, fracture regions 490 extend substantially along or entirely along the length of side wall 401 and may incorporate proximal and distal cut outs 406 and 452. Further, fracture regions 490 may be configured to flex to allow some radial expansion of the sheath before fracturing to allow even further radial expansion of sheath 400 (post fracture expansion is illustrated in
In the illustrative embodiment of
Concave side wall segments 405 may also include longitudinal flexion regions 480 to aid in allowing the wall segments to expand radially outward to fix graft material to a bone tunnel wall. As with fracture regions 490, flexion regions can extend substantially along or entirely along the length of side wall 401. Flexion regions 480 may also be formed by thinning the material of side wall 401 longitudinally in the region of desired flexion, and in one embodiment, may be a longitudinal groove cut into side wall 401.
In the illustrated embodiment, each concave side wall segment 405 includes two longitudinal flexion regions 480 which divide the wall segments into three relatively rigid longitudinal subsegments connected by the two longitudinal flexion regions. A person of ordinary skill in the art will recognize that a sheath of the invention could be formed using only one flexion region within a wall segment or by using more than two such flexion regions within the spirit of the invention.
In one embodiment of the invention, longitudinal fracture regions 490 (which preferably flex before fracturing) have a convex outer surface and act as “outer hinges,” while longitudinal flexion regions 480 act as “inner hinges” to allow a first measure of radial expansion toward a circular geometry by flexing of these inner and outer hinges. This first measure of radial expansion can be followed by fracture of one or more of the longitudinal fracture regions 490 to provide a second measure of radial expansion beyond the first measure.
The provision of inner 480 and outer 490 hinges in sheath 400 provides resiliency and malleability to side wall 401 and allows for the option of using stiffer, stronger starting stock for sheath 400 than would otherwise be possible. Both inner hinge flexion regions 480 and outer hinge fracture regions 490 serve as concentrated bending areas. However, fracture regions 490 are preferably configured to act as regions of maximum stress as there is less or no graft material 28 to counterbalance radial stresses. If side wall 401 is to fail at any location for lack of ductility or strength, this embodiment allows for breakage to occur at fracture regions 490, further illustrated in
Further, such controlled rupture along fracture regions 490 facilitates use of a wider variety of expander sizes, including the use of expanders having an outer diameter or circumference at least as large as the diameter or circumference of sheath 400. In this way, a single sheath size may be stocked for a wide variety of procedures and intended bone tunnel sizes. In one embodiment, sheath 400 may be provided in a kit to surgeons in which a plurality of expanders having different sizes are provided for use with a single size sheath.
The inclusion of fracture regions 490 and/or flexion regions 480 widen the choice of available sheath materials to include, for example, biocompatible bioabsorbable polymers selected from the group consisting of aliphatic polyesters, polyorthoesters, polyanhydrides, polycarbonates, polyurethanes, polyamides and polyalkylene oxides. Sheath 400 may also be formed from absorbable glasses and ceramics (possibly comprising calcium phosphates and other biocompatible metal oxides (i.e., CaO)). Sheath 400 may also be formed from metals; it can comprise combinations of metals, absorbable ceramics, glasses or polymers.
In further embodiments, the expandable sheath may be fabricated from aliphatic polymer and copolymer polyesters and blends thereof. Suitable monomers include but are not limited to lactic acid, lactide (including L-, D-, meso and D,L mixtures), glycolic acid, glycolide, E-caprolactone, p-dioxanone (1,4-dioxan-2-one), trimethylene carbonate (1,3-dioxan-2-one), delta-valerolactone, beta-butyrolactone, epsilon-decalactone, 2,5-diketomorpholine, pivalolactone, alpha, alpha-diethylpropiolactone, ethylene carbonate, ethylene oxalate, 3-methyl-1,4-dioxane-2,5-dione, 3,3-diethyl-1,4-dioxan-2,5-dione, gamma-butyrolactone, 1,4-dioxepan-2-one, 1,5-dioxepan-2-one, 6,6-dimethyl-dioxepan-2-one, 6,8-dioxabicycloctane-7-one and combinations thereof. These monomers generally are polymerized in the presence of an organometallic catalyst and an initiator at elevated temperatures. The organometallic catalyst may be tin based, (e.g., stannous octoate), and may be present in the monomer mixture at a molar ratio of monomer to catalyst ranging from about 10,000/1 to about 100,000/1. The aliphatic polyesters are typically synthesized in a ring-opening polymerization process. The initiator is typically an alkanol (including diols and polyols), a glycol, a hydroxyacid, or an amine, and is present in the monomer mixture at a molar ratio of monomer to initiator ranging from about 100/1 to about 0.5000/1. The polymerization typically is carried out at a temperature range from about 80° C. to about 240° C., preferably from about 100° C. to about 220° C., until the desired molecular weight and viscosity are achieved.
It is to be understood that the present invention is by no means limited to the particular constructions and methods herein disclosed and/or shown in the drawings, but also comprises any modifications or equivalents within the scope of the claims
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|U.S. Classification||623/13.14, 606/232, 623/13.15, 606/151, 606/60|
|International Classification||A61F2/08, A61B17/56|
|Cooperative Classification||A61F2/0811, A61F2002/0858, A61F2002/0882, A61F2002/0829, A61F2002/0835, A61F2002/0888, A61F2002/0852|
|Jul 26, 2010||AS||Assignment|
Owner name: DEPUY MITEK, INC., MASSACHUSETTS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ETHICON, INC.;REEL/FRAME:024737/0727
Effective date: 20031229
|Dec 20, 2011||CC||Certificate of correction|
|Apr 15, 2015||FPAY||Fee payment|
Year of fee payment: 4